Brand Name | NEUROFORM ATLAS 4.5MM X 15MM NO TIP - CE |
Type of Device | STENT, INTRACRANIAL NEUROVASCULAR |
Manufacturer (Section D) |
STRYKER NEUROVASCULAR CORK |
ida industrial estate |
model farm road |
cork NA |
EI NA |
|
Manufacturer (Section G) |
STRYKER NEUROVASCULAR CORK |
ida industrial estate |
model farm road |
cork NA |
EI
NA
|
|
Manufacturer Contact |
tara
lopez
|
47900 bayside parkway |
fremont, CA 94538
|
5104132500
|
|
MDR Report Key | 19029219 |
MDR Text Key | 339232518 |
Report Number | 3008881809-2024-00143 |
Device Sequence Number | 1 |
Product Code |
NJE
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P180031 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/02/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | M003EZAS45150 |
Device Lot Number | 24337115 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/02/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | SL-10 MICROCATHETER (STRYKER).; SYNCHRO2 GUIDEWIRE (STRYKER). |
Patient Age | 61 YR |
Patient Sex | Male |
Patient Weight | 68 KG |
Patient Race | Asian |